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artus BK Virus PCR Kits CE

For quantitative detection of BK virus specific DNA using real-time PCR
  • Complete CE-IVD-compliant workflow (QIAsymphony RGQ)
  • High reliability using the internal control
  • Highly sensitive detection of as few as 26.7 copies/ml (QS-RGQ kit)
  • Accurate quantitation using the 4 standards supplied
The artus BK Virus RG PCR Kit and the artus BK Virus QS-RGQ Kit are ready-to-use molecular detection kits for real-time PCR on Rotor-Gene instruments. The kits provide all necessary reagents optimized for rapid and sensitive detection of BK virus specific DNA with highly accurate quantitation of viral load for in vitro diagnostic use. The artus BK Virus RG RT-PCR Kit uses automated sample preparation and manual assay setup techniques. The artus BK Virus QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup.
Cat No./ID: 4514263
artus BK Virus RG PCR Kit (24) CE
For 24 reactions on Rotor-Gene Q instruments: Master, 4 Quantitation Standards, Internal Control, Mg Solution, Water (PCR grade)
Cat No./ID: 4514265
artus BK Virus RG PCR Kit (96) CE
For 96 reactions on Rotor-Gene Q instruments: Master, 4 Quantitation Standards, Internal Control, Mg Solution, Water (PCR grade)
Cat No./ID: 4514363
artus BK Virus QS-RGQ Kit (24) CE
For 24 reactions on the QIAsymphony RGQ: Master, 4 Quantitation Standards, Internal Control, Mg Solution, Water (PCR grade)

artus BK Virus PCR Kits CE are intended for in vitro diagnostic use in Europe.


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Reliable quantitation of BK virus load.
Detection of the quantitation standards (BK Virus RG QS 1–4) on the Rotor-Gene Q using the artus BK Virus RG PCR Kit. NTC: no template control.
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Highly sensitive detection of BK virus DNA.
Probit analysis: plasma, BK Virus (Rotor-Gene Q). Analytical sensitivity in consideration of the purification (QIAsymphony DSP Virus/Pathogen Midi Kit) of the artus BK Virus QS-RGQ Kit on the Rotor-Gene Q.
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CE-IVD-marked.
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In vitro diagnostic medical device.
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Integrated QIAsymphony RGQ system for BK virus detection.
Performance

To ensure highest sensitivity, artus BK Virus Kits have been optimized to detect low numbers of BK virus DNA. The analytical sensitivity of the artus BK Virus QS-RGQ Kit is 26.7 copies/ml in consideration of the purification from plasma and assay setup using the QIAsymphony RGQ (see figure "Highly sensitive detection of BK virus DNA"). The specificity of the kits has been tested with the relevant BK virus strains.

Performance characteristics of artus BK Virus Kits
Kit  artus BK Virus RG PCR Kitartus BK Virus QS-RGQ Kit
Validated sample types  Human plasma or urine Human plasma or urine
Analytical sensitivity  0.195 copies/μl in the PCR 26.7 copies/ml in consideration of the purification (plasma)
 Linear range  n.d.  5.00 x 101 to 9.26 x 107 copies/ml (plasma)
 Specificity  BK virus (tested with strains Dunlop, Gardner, AB269822, and S72390)  BK virus (tested with strains Dunlop, Gardner, AB269822, and S72390)
n.d.: not determined.

Principle

The artus BK Virus RG PCR Kit and the artus BK Virus QS-RGQ Kit are based on the amplification and simultaneous detection of a specific region of the BK virus genome using real-time PCR. The kits provide high levels of specificity, sensitivity (see figure "Highly sensitive detection of BK virus DNA"), and reproducibility.

Each artus BK Virus Kit provides 4 BK virus quantitation standards (see figure "Reliable quantitation of BK virus load"). Use of the standards enables accurate quantitation of viral load. In addition, the kits contain a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical BK virus PCR is not reduced.

Specifications of artus BK Virus Kits
Kitartus BK Virus RG PCR Kit and artus BK Virus QS-RGQ Kit
Validated sample types Human plasma or urine
Amplicon 274 bp region covering parts of the VP2 and VP3 genes

Procedure

artus BK Virus Kits provide all necessary reagents optimized for reliable BK virus DNA detection and quantitation. Simply add template DNA to the ready-to-use PCR master mix and Mg solution, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

Common temperature profiles for multiple assays in one run

The temperature profile of artus BK Virus Kits corresponds to the profiles of the artus RG PCR Kits and artus QS-RGQ Kits for EBV, CMV, HSV-1/2, and VZV. Therefore, these PCR assays can be performed and analyzed in a single run.

Complete automated system from sample to BK virus detection

The QIAsymphony RGQ workflow solution for BK virus detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus BK Virus QS-RGQ Kit on the Rotor-Gene Q. The system enables reliable pathogen detection with a complete CE-IVD-compliant workflow (see figure "Integrated QIAsymphony RGQ system for BK virus detection").

Recommendations for viral DNA purification when using the artus BK Virus RG PCR Kit

The artus BK Virus RG PCR Kit is validated for use with the EZ1 DSP Virus Kit. The artus BK Virus RG PCR Kit is also available as CE-IVD-marked EASYartus BK Virus RG PCR Kits, which include the EZ1 DSP Virus Kit for automated viral nucleic acid purification.

Applications

The artus BK Virus RG PCR Kit enables rapid and sensitive detection of BK virus DNA from human plasma or urine samples with highly accurate quantification. The kit is available for use on Rotor-Gene Q instruments.

The artus BK Virus QS-RGQ Kit is designed to be used with the QIAsymphony RGQ system, providing a complete CE-IVD-compliant workflow from plasma or urine samples to BK virus DNA detection and quantitation.

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Protocol Files (1)
For use with QIAsymphony SP/AS instruments (software version 4.0)
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Instrument Technical Documents (1)
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